Implementation of a “Patient Blood Management” program in medium sized hospitals: Results of a survey among German hemotherapists

Abstract Background and aims Germany uses more blood transfusions than the majority of other countries. The objective of this study was to detect the degree of Patient Blood Management (PBM) implementation within Germany and to identify obstacles to establishing PBM programs. Methods An electronical questionnaire containing 21 questions and 4 topics was sent in 2018 to the members of the German interdisciplinary hemotherapy (IAKH) society in Germany. The degree of PBM (described as pre‐, intra‐, postoperative period) was established via questions within the topics “management of preoperative anemia” (PA) (n = 5), “preoperative management and transfusion preparation” (n = 3), PBM organization and structure (n = 5), coagulation management (n = 3), perioperative transfusion performance and habits (n = 3), best practices and problems (n = 2). Results 533 German hospitals with transfusion activity received the questionnaire with a 32.5% response rate to the survey. A dedicated PBM program had not been established in a quarter of all small and medium sized institutions. Red blood cell transfusion was the only therapeutic option in a third of institutions. Approximately half of the hospitals did not use knowledge of PA rates or transfusion needs of surgical procedures. Institutions failed to implement PBM because of a lack of profit, workload, personnel shortage, and administrative support. Conclusion PBM was not present in at least a quarter of the hospitals interrogated. Factors for improvement were the relationship between health care disciplines and sectors, economic incentives, inclusion of relevant disciplines, and the structure of the blood industry. To improve BPM implementation, hospitals need support to implement top‐down PBM projects.


| INTRODUCTION
A recent audit in Europe reported considerable variation in the degree of Patient Blood Management (PBM) implementation across 10 surveyed centers. 1 In Germany, orthopedic and cardiothoracic disciplines perform hemotherapy by transfusing autologous blood components. Stimulated by international publications, the PBM concept was a constant focus in Germany's scientific meetings for more than 10 years. The concept was addressed to clinicians as a bottom up strategy, since they are the ones administrating blood products to patients. Later on, a joint project of PBM from a University Hospital and public media addressed all shareholders such as patients and health care officials through a TV report about practical blood use. 2 However, the following question arose: to what degree has the concept been implemented after a decade? Recent reports demonstrated that initiating the process of implementing PBM as a three-column program was very difficult 3 all over Europe.
In Germany specifically, PBM levels seemed to be underdeveloped compared to other countries in Europe. An analysis of a large German health insurance company identified a waste of 1 million units of packed red cells (PRC) per year. 4 In round 1200 german hospitals, with little variation over the last decade, approximal 3 Mio PRC were needed. In this context, obstacles to implementing and maintaining all PBM elements are still unclear.
Unlike other countries, blood transfusion is an easy and inexpensive therapy in Germany. The acquisition cost for a unit of leukocyte-depleted packed red blood cells range from 80 to 120€, which includes the cost of delivery, testing, and over-night fees.
Allogeneic red blood cell units are usually from voluntary donors at blood donation services located outside of hospitals. In contrast, PBM implementation needs additional time, energy and manpower. A clear return-of-investment margin for the hospital is less likely as the savings are slim. Bottom-up-implementation of PBM requires physicians to actively develop a convincing economical argument.
The smaller the institution, the less likely personnel, time and financial resources are available. Thus, it can be difficult for small to medium size hospitals to successfully implement a higher level of PBM.
However, in Germany, the majority of blood products are transfused in these smaller hospitals ( Figure 1). 5,6 Among the 2525 blood using institutions and approximal 1200 hospitals that were reporting blood consumption in Germany in 2018 (median n = 1216 PRC in 2018), transfusion of PRC in hospitals with less than 500 beds is contributing to a major part to the nationwide consumption of blood products. Thus the practice habits in the smaller hospitals would be more relevant than those in the few university health care level I centers. In the latter, a high(er) degree of implementation can be assumed due to their initiative of PBM proclamation. However, neither the status of implementation nor the existence of potential barriers to a German PBM in smaller institutions were known.
Moreover, the German transfusion structure differs considerably from other European countries. In Germany, quality management and hemovigilance is devolved to "transfusion officers and commissioners" (see German transfusion law 7 ). A dedicated F I G U R E 1 Blood Product use in Germany by number of hospitals. The number of packed red cells (PRC) is increasing from left to right. Columns represent the hospitals of the respective category (PRC use). Since among German hospitals (n = 1925 in 2018), smaller and medium size hospitals (less than 500 beds, n = 1584) are outnumbering bigger level one centers (500 and more beds, n = 280) by far, 5 the conclusion is that small and medium size hospitals are contributing to the general transfusion activity in Germany considerably. Nationwide Trend data (not shown 6 ) show that the number of transfusion activity reporting hospitals (approx. n = 1200) as well as the number of transfused PRCs (approx. 3 Mio) did not change much over the last decade. With permission from Thieme. 5 transfusion law regulates a personal division of responsibility for the quality of hemotherapy, while practical hemotherapy is performed by clinicians of every discipline in adherence to medical guidelines. 8,9 The surveillance personnel of commissioners and officers does not necessarily include their involvement in diagnosis and treatment of anemia. Diagnosis of anemia is mostly performed by hematologists and oncologists; coagulation disorders require therapy from hemostaseologists. Anesthesiologist are in charge of perioperative management, including cell salvage. 10 Because hemotherapy involve a multiplicity of responsibilities and players, implementation of a PBM concept might be more difficult in Germany than elsewhere.
Perioperative aspects of PBM include various other clinical specialties. Therefore, the concept was spread for most of surgical and conservative clinical departments although dedicated PBM programs for nonsurgical specialties that is, oncologists were promoted be only a few societies in Germany.
To get reliable data about the PBM implementation throughout Germany, the "Interdisciplinary Working Group of Clinical Hemotherapy," (IAKH, www.iakh.de, one of the promoting societies) sent a questionnaire to the members of the society to interrogate about the PBM implementation status of their affiliated hospitals. Since the IAKH supports the education of dedicated hemotherapists by evidence transfer to small and middle size institutions, their members would give a realistic status report about PBM implementation. In this article, we state the responses in detail and discuss the German-wide implementation status.

| MATERIALS AND METHODS
The survey questions were created by the research team, an advisory board from quality assurance, data management of IAKH, and the local medical association. Two experts in the field were asked to review all items of the questionnaire. An ethical committee was not necessary for this survey because there were no human subjects involved. Quality management and structure, (8) Best practice.
Since the questionnaire was conducted in German, we translated the questions to English for purposes of the manuscript. The translated questions are listed in Table 1. The majority of questions (n = 19) have either five to seven predetermined potential answers to choose from, or an additional field listed as "other" for responders to type in their own responses. Two of the 19 questions were open ended. These questions were (1) to name one best hemotherapy practice example that is performed in their own hospital better than in other hospitals and (2) the difficulties in PBM introduction and implementation, management and the support required for the implementation.
The responses were transferred to Excel (vs. 16.16.4). Data analysis was descriptive. Since a detailed statistical analysis is not necessary to describe the survey's results, there were no significance level and methods to define.

| RESULTS
The response rate to the survey was 32,5% (174 answers from 533 members of the IAKH hemotherapy society). About 64.4% of answers were received from small and medium size hospitals Members of larger hospitals made 35.2% of the replies, of which 19.2% of answers came from institutions with 8000 to 12,000 surgical interventions per year, 4.8% between 12,000 and 16,000, and 11.2% more than 16,000 surgeries per year ( Figure 2).

| Transfusion risk assessment
From those institutions that had a SOP guided blood order schedule (BOS) as a preparation for major blood loss and perioperative transfusion, 58% were based on estimates of surgeons or experts.
32% of responders prepared their BOS according to the consumption of actual cases. About one in every 10 institutions (9%) used blood bank data (consumption and unused reservations per procedure) for BOS. In one institution, the BOS was not kept up to date and another responder adapted the statistical data derived estimated blood loss (EBL) based on their personal experience. In 4% of all responding institutions, the EBL of procedures was completely unknown.
Total blood volume or erythrocyte mass were calculated, if necessary, for special cases in 35% of institutions. In 64% of responding FRIETSCH ET AL.
institutions, the relationship of EBL and patient's erythrocyte mass was not considered for preparation of red blood cell concentrates before surgery. One response given was that this method was declined by the transfusion commission of that institution.

| PBM program and performance
The concept and program of PBM was introduced and maintained by the departments of anesthesiology (47%), transfusion medicine (11%), internal medicine (4%) or surgery (15%, containing all surgical disciplines). Surgery included abdominal surgery (5.6%), cardiac (2.3%), vascular (3.4%), gynecology/obstetrics (1.1%) and urology (2.3%). Twenty-six percent of all institutions surveyed did not have an established PBM program. In 7.5% of the responding institutions, PBM was in the process of implementation, but had not yet been established at the time of survey. The major cause for failing to implement PBM was the lack of profit and reimbursement in relationship to an expected workload from the organization itself, a required change in management and complex interdisciplinary and intersectoral networking (25%). The other causes included the lack of available personnel resources (work overload and/or lack of staff in 15%), lack of interest and/or information of surgeons (12.5%), delay of elective surgery (12.5), resistance and lack of interest by hospital directory board (7.5%), rigid health care structures and lack of interest from nonhospital care physicians to participate (10%) in the program. Diagnosis and therapy of PA especially was seen as a hindrance to program implementation (12.5%) since hemoglobin levels were either taken too late for adequate anemia therapy, or were considered tolerable in most cases of "mild" anemia. Two trauma centers were unable to establish a PBM program due to their quick scheduling for urgent surgical procedures.
T A B L E 1 IAKH Questionnaire-PBM status in Germany 1 How many surgical procedures were performed in your institution last year/annually? 3.3 | Preoperative Anemia (PA)

| Diagnosis
In nearly half of the responding institutions, the rate of PA was unknown ( Figure 3). Hemoglobin levels before surgery were taken 1 day before surgery (57.1%), at the day of surgery (0.95%), 3 to 5 days before admission (23.8%) or up to 3 weeks before surgery (12.4%). In 77% of institutions, hemoglobin levels were unknown until the week before surgery. Measurements of Hb levels more than 7 days before surgery was only stated in 16% of treated patients.
Only 20% of hospitals determined patient hemoglobin levels by their general practitioner or referring specialists. Nine percent of hospitals used noninvasive plethysmography as a screening tool for anemia. If a low hemoglobin concentration is detected, a proper laboratory work up for the blood based quantification, red cell morphometry, and causal diagnosis for iron deficiency or others is performed usually, according to an actual anemia guideline. More than half of institutions (56%) used automated cell counters as a method of inhospital hemoglobin measurement. Solely hemoglobin content was taken in 5% of institutions and further diagnostics eventually followed. An algorithm for anemia diagnosis was stated in only 1% of hospitals. Anemia assessments were analyzed by either ferritin levels alone (10.1%) or with additional transferrin saturation (16.2%).
Although it was not a routine standard, reticulocyte hemoglobin was analyzed by 10.1% of hospitals. A preoperative calculation of the individual red cell mass and/or plasma volume was very rarely used ( Figure 5).

| Therapy
In more than a third of the responding institutions (35%), management of PA was restricted to perioperative red blood cell transfusions. It was common in 24.7% of institutions to start adequate anemia therapy more than a week before surgery. Most institutions (47.1%) began therapy within the week before surgery (Figure 4). referring specialist (19.3%), cooperating ambulatory healthcare center (7.1%), dedicated PBM unit/autologous donation unit within the hospital (7.2%), admission unit (4.8%), patient logistics (3.6%), and/or the hematologist (1.2%) ( Figure 6).

| Transfusion practice
A common practice within institutions was to order double units of PRC as opposed to a single unit order: 41% of the responding institutions noted that double units were ordered in 20% to 80% of all orders (see Figure 8). One-third of the responses (33.1%) indicated F I G U R E 4 Time for preoperative measurement of hemoglobin content in elective surgery. The answers (n = 89) to question 3 ("In your institution, when do you measure hemoglobin content before elective surgery in more than 50% of procedures]?") show that in Germany, the majority of patients were admitted the day before surgery and tested for hemoglobin contents.

| Difficulties in PBM implementation, management or the support required
The difficulties of implementing PBM are listed in Table 3 15 The implementation rather can be initiated by blood product producers with profit interest than by affected stakeholders such as patients and blood product users. The ideal mix between top-down and bottom-up obviously varies but has not been achieved for PBM in Germany yet.

ACKNOWLEDGMENTS
The authors thank the IAKH (www.iakh.de) for the use of their electronic infrastructure including membership database and the technical support of A. Hinrichs with the conductance of the survey.
For critical review of the manuscript, we thank P. Meybohm and K. Zacharowski. The IAKH society provided the electronic system for the survey tool and the publication fee. The IAKH was not involved in analysis, and interpretation of data; writing of the report; the decision to submit the report for publication.The corresponding author T. F. affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; no important aspects of the study have been omitted; no discrepancies from the study as planned has to be explained.

CONFLICT OF INTEREST
T. F. had limited consultant contracts with Janssen Cilag, Haemonetics, Vifor Pharmaceuticals and Pharmacosmos and received honoraria for scientific lectures from Janssen Cilag and Astra Zeneca, travel reimbursements from Janssen Cilag, Astra Zeneca, Braun, Behring CSL in the past.
The remaining authors declare no conflict of interest.

DATA AVAILABILITY STATEMENT
The authors confirm that the data supporting the findings of this study are available on www.Iakh.de

ETHICS STATEMENT
Ethical approval was not required or obtained, since neither patient's individual data nor personal involvement were requested. The contributing institutions and members of the IAKH rested unknown, because the response to the questionnaire was anonymous.

TRANSPARENCY STATEMENT
The lead author Thomas Frietsch affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.